Prescription drug · ANDA
Azithromycin Dihydrate NDC 70518-4160
Azithromycin dihydrate 250 mg/1 · Tablet, Film coated · Oral · REMEDYREPACK INC.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 70518-4160-0 | 70518416000 | 6 TABLET, FILM COATED in 1 BLISTER PACK (70518-4160-0)Marketed from Aug 15, 2024 | |
| 70518-4160-1 | 70518416001 | 30 TABLET, FILM COATED in 1 BLISTER PACK (70518-4160-1)Marketed from Aug 28, 2024 | |
| 70518-4160-2 | 70518416002 | 6 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-4160-2)Marketed from Sep 23, 2024 | |
| 70518-4160-3 | 70518416003 | 1 BLISTER PACK in 1 CARTON (70518-4160-3) / 6 TABLET, FILM COATED in 1 BLISTER PACKMarketed from Apr 2, 2025 | |
| 70518-4160-4 | 70518416004 | 2 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-4160-4)Marketed from Sep 13, 2025 | |
| 70518-4160-5 | 70518416005 | 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-4160-5)Marketed from Feb 1, 2026 |
How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules
Product information
- Brand name (proprietary)
- Azithromycin Dihydrate
- Generic name (nonproprietary)
- azithromycin dihydrate
- Active ingredients
- Azithromycin dihydrate — 250 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- REMEDYREPACK INC.
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 208250
- Marketing start
- Listing expires
- Other FDA classes
- Macrolides (Chemical structure)
- Identifiers
- Product ID 70518-4160_5a1b9873-bcfc-8b80-e063-6394a90ae6dfSPL ID 5a1b9873-bcfc-8b80-e063-6394a90ae6dfSPL set ID f0cfda1a-910f-4764-8658-263037df5ea8RxCUI 308460, 749783UNII 5FD1131I7S
- Pharmacologic class
- Macrolide Antimicrobial
Billing references
What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.
- HCPCS codeNo match
No HCPCS code in Med-Code's directory. Oral products like this are usually dispensed by a pharmacy and billed by NDC.
- NDC on a medical claim
N470518416000followed by a unit qualifier and the quantityPackage 70518-4160-00. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier
Product label
Label details couldn’t be retrieved right now. Open the label on DailyMed.
Other NDCs under ANDA 208250
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Azithromycin Dihydrate | Azithromycin dihydrate 250 mg/1 | Tablet, Film coatedOral | A-S Medication Solutions | 50090-4601 |
| Azithromycin Dihydrate | Azithromycin dihydrate 250 mg/1 | Tablet, Film coatedOral | DIRECT RX | 72189-089 |
| Azithromycin Dihydrate | Azithromycin dihydrate 250 mg/1 | Tablet, Film coatedOral | Preferred Pharmaceuticals Inc. | 68788-8800 |
| Azithromycin Dihydrate | Azithromycin dihydrate 250 mg/1 | Tablet, Film coatedOral | A-S Medication Solutions | 50090-4527 |
| Azithromycin Dihydrate | Azithromycin dihydrate 250 mg/1 | Tablet, Film coatedOral | Coupler LLC | 67046-1502 |
| Azithromycin Dihydrate | Azithromycin dihydrate 250 mg/1 | Tablet, Film coatedOral | Proficient Rx LP | 82804-182 |
| Azithromycin Dihydrate | Azithromycin dihydrate 250 mg/1 | Tablet, Film coatedOral | Redpharm Drug | 67296-2185 |
| Azithromycin Dihydrate | Azithromycin dihydrate 250 mg/1 | Tablet, Film coatedOral | PD-Rx Pharmaceuticals, Inc. | 72789-081 |
| Azithromycin Dihydrate | Azithromycin dihydrate 250 mg/1 | Tablet, Film coatedOral | Proficient Rx LP | 71205-430 |
| Azithromycin Dihydrate | Azithromycin dihydrate 250 mg/1 | Tablet, Film coatedOral | AvPAK | 50268-074 |
| Azithromycin Dihydrate | Azithromycin dihydrate 250 mg/1 | Tablet, Film coatedOral | NuCare Pharmaceuticals Inc. | 68071-3715 |
| Azithromycin Dihydrate | Azithromycin dihydrate 250 mg/1 | Tablet, Film coatedOral | TAGI Pharma, Inc. | 51224-022 |
| Azithromycin Dihydrate | Azithromycin dihydrate 250 mg/1 | Tablet, Film coatedOral | Asclemed USA, Inc. | 76420-046 |
| Azithromycin Dihydrate | Azithromycin dihydrate 250 mg/1 | Tablet, Film coatedOral | Advanced Rx Pharmacy of Tennessee, LLC | 80425-0218 |
| Azithromycin Dihydrate | Azithromycin dihydrate 250 mg/1 | Tablet, Film coatedOral | Quality Care Products, LLC | 83008-081 |
| Azithromycin Dihydrate | Azithromycin dihydrate 250 mg/1 | Tablet, Film coatedOral | PD-Rx Pharmaceuticals, Inc. | 72789-483 |
| Azithromycin Dihydrate | Azithromycin dihydrate 250 mg/1 | Tablet, Film coatedOral | Precision Dose, Inc. | 68094-900 |